Arab Republic of Egypt Side’. Agyall poe dyggar Egyptian Drug Authority Aw. Bpaal gal EDA-PT final Report Accreditation Programs Unit EDA- PT Program EDA-PT Program/-Accreditation programs unit 51 wezaret EL zeraast. EL Agouzs-Giza. Co-coordinator information ‘Name: Dr. Eman El Said E-mail: de.edapt@edaegypt-gov.eg Mobile: 01013651038 ‘Report 1D:1772023, Round No. :11CH.2023, |Scheme(s) ID: CHPH!10223, [HHP 111423 Issuedate:27/12/2023 [Sample (s) ID: 1040CH23, 1041CH23 Revision No. 00. | Revision Reason _| None [ ‘Customer/ Participant shail use the latest received version CONFIDENTIAL DOCUMENT Subcontracted activities Subcontractor Homogeneity and stability ‘CADC laboratories- PC 1 measurements for the Assay test by HPLC Scheme (CHHP111423) sa Ay paral gl gall Ath gall Aga WAYS, sai Mai Mobamed Talat 0) PoQaat Approved by EDA -PT program officer: Dr/ Eman Abdel Sayed © Accreditation programs unit mn: PER Dr/ Nehal Gamal El-din Wehe BHT Q 3 QF: CADC.001.06.01 Issue no/ Rev no:/3 Issue Date:1/11/2021 ‘Revision Date: 26/02/2023i ‘Arab Republic of E pee ay, a r lic of si ine’: Auayall pas yoga Egyptian Drug Authority Aypaall ely! dao EGAC i Accredited Proton Tsing caneenin SUMMARY For pH scheme | 1. PT sample 1040CH23 was despatched on 05/11/2023, test parameter was pH determination. 2, Total number of participants: 6, 3. Statistical methods: all statistical methods based upon ISO/IEC 13528:2022 4 Results for this Proficiency Testing are summarized as follows: | Summary Table: Assigned Value and Number of Satisfactory Scores Uncertainty ‘Number of : ] Aone value | Spassi satetacnny [Total ah Salen value scores a | pH 6.985 0.007 6 6 100% | For HPLC scheme 1. PT sample 1041CH23 and reference material 1041CH23-S were despatched on 06/11/2023, test parameter was Assay by HPLC. 2. Total number of participants: 14. 3. Statistical methods: all statistical methods based upon ISO/IEC 13528:2022 4, Results for this Prot Summary Table: Assigned Value and Number of Satisfactory Scores cy Testing are summarized as follows: labaad vi ‘Uncertainty ‘Number of i Ma eating vie es saicacory feelpambe | Satie value scores ‘Soares (%) ‘Assay by HPLC) 15.3, 0.152 | 13 14 92.9% 5. Whereas this report has been produced in good faith and in accordance with the best practices, EDA- PT program does not accept any liability whatsoever as to the application or use of the information contained therein. QF: CADC.001.06.01 Issue no/ Rev n0:1/3 Issue Date:1/11/2021 Revision Date: 2602/2023,Arab Republic of Egypt Egyptian Drug Authority Aaya)! pas dygger Iypaall egal dn Proficiency Testing em oan ‘Contents 1. INTRODUCTION L Proficiency Testing. 2.Confidentiality 3.Subcontracting services 2. TEST MATERIALS 1. Preparatio 2. Homogeneity and stability....... 3. Despatch... 3. RESULTS. 4, TATISTICAL EVALUATION OF RESULTS 1. Caloulation of the Assigned Value, Xp. . Standard Deviation for Proficiency Testing, op. . Evaluation of assigned value Uncertaint 2. 3 4, Performance Assessment... 5, . Trending participant PT results... 6. Traceability .... 7.Comments & technical advisors on participant’s performance 5. RESULT SHEET.. 6, REFERENCES... 7. TABLES, 8. FIGURES... QF: CADC.001.06.01 Issue no/ Rev no:1/3 Issue Date:1/11/2021 Revision Date: 26/02/2023‘Arab Republic of Egypt Ayal pas daygger Egyptian Drug Authority Aypaall elgull Zig Proiceney Fest ene i 1, INTRODUCTION 1.1, Proficiency Testing Proficiency testing aims to provide an independent assessment of the competence of participating laboratories. Together with the use of validated methods, proficiency testing is an essential tool of assuring the quality of the laboratory results, 1.2. Confidentiality All information submitted to EDA-PT program is kept strictly confidential and anonymous. In all reports issued by EDA- PT program, participants are referred to as “Lab XX”, where XX is a code number. Electronic communications conducted by official EDA email individually to each participant. 1.3. Subcontracting services “Subcontracted activities Homogeneity and sta for the HPLC scheme(CHHP111423) ity measurements 2. TEST MATERIALS 2.1. Preparation 21.1. For pH scheme + pH CRM buffer solution from ISO 17034:2016 certified supplier was used as PT samples; samples were packaged in strictly closed amber bottles labeled with the sample data and storage conditions without any pretreatment. 2.1.2. For HPLC scheme © Commercially available products “tablets” were used as PT samples, EDA-PT technical supervisor grinded carefully the commercial tablet until obi homogenous fine powder mixture. QF: CADC.001.06.01 Issue no/ Rev n0:1/3 Issue Date:1/11/2021 Revision Date: 2602/2023,Arab Republic of Egypt Aayall pas dyggar Egyptian Drug Authority spall elgll Ata Accredited Profceney Testing cansorzias Cee ees) forces Pence r) ‘+ Samples were packaged immediately in strictly sealed containers labeled with the sample data and storage conditions without any pretreatment. 2.2, Homogeneity and stability (for HPLC scheme only) ‘© For homogeneity measurements; randomly 11 finally packed test materials were selected and analyzed in duplicate. The test portions were labeled as “1a”, “1b”, “2a”, “2b” ete. where all (a) portions represented group A and all (b) portions represented group B ‘Note: all a& b portions are analysed randomly. ‘© Measurements were subcontracted to “physicochemical 1” laboratory within CADC. © Stability measurements were done on 3 selected finally packed samples at the end date of the round also transportation stability for one control sample was all done in duplicates, ‘© All measurements were conducted at repeatability conditions. ¢ EDA-PT statistician performed the study and data showed sufficient homogeneity and stability, 2.3. Despateh 23.1. For pH scheme ‘The Despatch date was on 05/11/2023. Test materials were sent to 6 participants for pH Scheme. 2.3.2. For HPLC scheme ‘The Despatch date was on 06/11/2023. Test materials were sent to 14 participants for Assay by HPLC Scheme. 3. RESULTS ‘The instructions for reporting results were as follows: 3.1. For pH scheme ‘© Results shall be reported as pH unit, 2 decimal places. ‘© Reporting of uncertainty was optional. QF: CADC.001.06.01 Issue no/ Rev no:1/3 Isoue Date:1/11/2021 Revision Date: 26/02/2023‘Arab Republic of Egypt 7a’. Aaya! pee Lygger Eeyptian Drug Authority ‘Aw Bapaall algal Sign ; EGAC Accredited i Prot Testing ‘caneoas hom ee) (ren ieresie ts) 3.2. For the HPLC © Results shall be reported results as mg/ 100 mg, one decimal places. © Reporting of uncertainty was optional. 4, STATISTICAL EVALUATION OF RESULTS | 4.1. Calculation of the Assigned Value, Xx 4.1.1. For the pH scheme ‘¢ Assigned values were derived from CRM value, 4.1.2. For the HPLC scheme Assigned values were derived from consensus value from the participant results. i 4.2. Standard Deviation for Proficiency Testing, opt 4.2.1. For pH scheme + The ox was taken from the repeatability and reproducibility standard deviations from a | previous collaborative study of precision of a measurement method based on ISO/ IEC 13528 clause 8.5*perception of experts” 42.2, For HPLC scheme Standard uncertainty for the PT scheme is derived from the general model based on the Horwitz Equation modified by Thompson based on ISO 13528:2022(E) 4.3. Evaluation of assigned value uncertainty 43.1. For pH scheme ‘* Uncertainty was taken from the COA of the buffer 43.2. For HPLC scheme * Uncertainty is calculated by using robust standard deviation ISO 13528:2022 clause 7.7.7 F where; S* is the robust standard deviation and P is the no. of participants UKpt)=1.25. QF: CADC.001.06.01 —Issueno/Revno:13 Issue Date:1/11/2021 Revision Date: 26/02/2023,‘Arab Republic of Egypt Agyall poe dygger Egyptian Drug Authority pall lg Aina EGAC Aceredited ficiency Testing Canadas Ro reas em ec 4.4, Performance Assessment For both tests the Participants’ Z-scores were calculated using the following equation: Xi Xp Z-Score- ~ —_, Where X\= the participant’s reported result, Xe the assigned value and opi= the standard deviation for proficiency. Where, [252 satisfactory, 2<\z}<3 questionable and |22>3 non-satisfactory. 4.5. Trending participants’ PT results 45.1. For pH scheme © 100% of z-scores lied in the range of. z|<2 All participants didn’t evaluate uncertainty as “optional” 4.5.2. For HPLC scheme © 92.9% of z-scores are in the range of. [<2 © 7.1% of z-scores are in the range of 2<|2/<3 questionable © All participants didn’t evaluate uncertainty as “optional” 4.6. Traceability ‘+ Alll subcontracted measurements and dispatching activities were conducted by calibrated equipment and reference standards traceable to the SI unit. ‘+ Buffer 7 used in pH test is CRM provided by an ISO 17034:2016 accredited supplier 4.7. COMMENTS& TECHNICAL ADVICE ON PARTICIPANTS’ PERFORMANCE + For Satisfactory Results: that indicate satisfactory performance and good technical practices which require maintaining the same level of competencies through continuous and sustained training and implementation of good laboratory practice using calibrated equipment + For Questionable Results; the lab shall investigate the result considering but not limited to equipment status, competency, calculations, storage conditions, method adherence, etc. QF: CADC.001.06.01 Issue no/ Rev no:1/3 Issue Date:1/11/2021 Revision Date: 26/02/2023Arab Republic of Egypt Egyptian Drug Authority 5, RESULT SHEET 5.1. For pH scheme Labeode |” Result (Z-score) on 0.60 06 0.20 07 0.46 10 0.20 rT 020 17 033 5.2. For HPLC scheme Lab. ode |” Result (Zseore) 02 “104 03 -0.01 04 128 05 “026 08 128 a 025 2 153 B “078 [a4 =L04 15 0.78 16 =104 3! 2.05 20 052 QF: CADC.001.06.01 Issue no/ Rev 0:1/3 EGAC Accredited Proficiency Testing CABHOTRIGS Aral elgull ign Coins Issue Date:1/11/2021 Revision Date: 26/02/2023‘Arab Republic of Egypt Ayal! pas dyyggar Egyptian Drug Authority Aypaall ely! dio EGAC Accredited Proiiene Testing Capa bn remo) ere) frei ieee) 6, REFERENCES 6.1. ISO/IEC 17043:2010, Conformity assessment — General requirements for proficiency testing. 6.2, ISO 13528:2022, 7. TABLE, 7.1 Evaluation of Performance 7.1.1. For pH scheme Zseore x me ovr Result Evaluation oO 7.03 6.985 0.075 0.60 Satisfactory 06 697 CRM r&R -0.20 Satisfactory 7 7.02 046 Satisfactory 10 7.00 0.20 Satisfactory i 7.00 0.20 Satisfactory 7 701 033 S QF: CADC.001.06.01 Issue no/ Rev no:i/3 Issue Date:1/11/2021 Revision Date: 26/02/2023,Arab Republic of Egypt Aus! pas dyogar Egyptian Drug Authority Aapaall elyall Aix PCAeeeR 7.1.2. For HPLC scheme Zscore Lab. Code xi = or Result Evaluation a 14.90 153 0389 “1.04 Satisfactory General “oo Satisfactory 03 Algorithm A Model 4 Satisfactory 5 Satisfactory [08 Satisfactory 0 Satisfactory 2 Satisfactory 13 Satisfactory 4 =104 Satisfactory 15, 0.78 ‘Satisfactory [16 -1.04 Satisfactory 18 19 0.52 Satisfactory [207 [15.10 “052 Satisfactory ‘indicates Questionable result QE: CADC.00L.06.01 Issue no/ Rev n0:1/3 Issue Date:1/11/2021 Revision Date: 26/02/2023‘Arab Republic of Egypt Ayal pas Anggar Egyptian Drug Authority Aypaall elgall digo cap eor3ia3 Cia 7.2. Statistical Summary 7.2.1. For pH scheme Parameter Result Starting date of the Round W/Nov/2023 Round NO. TICH2023 Total No of Satisfactory result | 6 No of Passing lab 6 No of Questionable result 0 | Noofnon-satisfactory result = [0 ee Mean without outlier No outliers et MEDIAN Z 7.01 MADe() 0.015 nIQR(x) 0.013 Ucra 0.007 QF: CADC.001.06.01 —Issueno/Revno:1/3 Issue Date:1/11/2021 Revision Date: 26/02/2023Arab Republic of Egypt Egyptian Drug Authority Ayal pas dygger Aapaall alg! ag Proficeney Testing Canora oa age n 7.2.2. For HPLC scheme Parameter Result Starting date of the Round TNovi2023 Round NO. T1CH2023 - | Total No of Satisfactory result 4 No of Passing lab B No of Questionable result : 1 ee cH No of non-satisfactory result 0 ‘Algorithm A Mean 153 Outlier lab code - ‘None ‘Mean without outlier 153 ‘Algorithm A STD 0.459 [MEDIAN 132 ea MADe(x) 0371 nlQR(x) 0.547 | U of assigned value [0.153 Peer QF: CADC.001.06.01 Issue no Rev no:1/3 Issue Date:1/11/2021 Revision Date: 26/02/2023,Arab Republic of Egypt one, Pate. Agyall_ pao Qygger Egyptian Drug Authority at Apa! sg dian Protcieney Testing Babies “Tine foie 8. Figures 8.1.For pH scheme Scatterplot of participants’ results for scheme ID PH110223 aml : re 2 19 3 4 wy F700| ea a” eon | 1 Figure 1 Participants’ results seatterplot QF:CADC001.06.01 Issue no/ Rev n0:1/3 Revision Date: 26/02/2023,‘Arab Republic of Egypt Egyptian Drug Authority Figure 2 Z-Score Ayal pas dygger Aspasl ell Aye Proficiency eating cABHOTRIOG 06: os a] 03 oz on 0: ot 02) 03 eee - ——: - Z- score Chart QF: CAPC.001.06.01 Issue no/ Rev mo:1/3 Issue Date:1/11/2021_Revision Date: 26/02/2023‘Arab Republic of Egypt Ayal poe dagger Egyptian Drug Authority yp! elgill Aig Protein Texine cabana ian Histogram for Scheme ID CHPH110223 20. 15 100 «Tot 7203 Lab Xi Figure3 Histogram of participants’ results QF:CADC001.06.01 Issue no/Revno:1/3 Issue Date:1/11/2021 Revision Date: 26/02/2023‘Arab Republic of Egypt Ayal! pas &yggar Egyptian Drug Authority Ayal ely! digo Profieney Testing CAB qOrzI0S | ren ba 8.2.For HPLC scheme Scatterplot of participants results weap ‘ eae | 160 i: ‘ 8 t 8 ° . 55) S 3 tba ° 3 Pees 152 . yw Ee 3 180. : 2 % : o 5 6 : Figure4 Parti ants? results scatterplot QF: CADC.001.06.01 Issue no/ Rev no:1/3 Iseue Date:1/11/2021 Revision Date: 26/02/2023Arab Republic of Egypt Egyptian Drug Authority Ayal pas Anoger Aapaal egal yn Proficiency Testing eapnorzias Figure Z-seore Chart QF: CADC.001.06.01 Issue no/ Rev n0:1/3 Issue Date:i/11/2021 Revision Date: 26/02/2023,‘Arab Republic of Egypt Ayyall pas dygger ' Egyptian Drug Authority Aypaall elyall Aig Proficiency Testing CABH OTIS Figure 6 Histogram of participants’ results QF: CADC.001.06.01 Issue mo/ Rev mo:1/3 Issue Date:1/11/2021_Revision Date: 26/02/2023